Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2021-03-01

Brief Summary

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The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment

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Detailed Description

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Conditions

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Prolapse Genital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic promontofixation

Group Type ACTIVE_COMPARATOR

promontofixation

Intervention Type PROCEDURE

reconstruction of cystoceles using a subvesical prosthesis

Anterior vaginal sacrospinofixation

Group Type EXPERIMENTAL

sacrospinofixation

Intervention Type PROCEDURE

Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route

Interventions

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promontofixation

reconstruction of cystoceles using a subvesical prosthesis

Intervention Type PROCEDURE

sacrospinofixation

Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient must be available for 12 month follow-up
* Patient is ≥50 and \<80 years old
* Patient has pelvic prolapse stage 2 or above according to international POP-Q score, concerning the anterior and apical compartments, justifying surgical treatment
* Patients not having preoperational stress urinary incontinence or having mild stress urinary incontinence not causing significant functional problems (response \<2 to question 17 of PFDI-20 questionnaire). It is possible that patients with hidden stress urinary incontinence will be recruited

Exclusion Criteria

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
* The subject refuses to sign the consent
* Patient with communication issues preventing comprehension of information and administration of questionnaires
* Pelvic prolapse not affect anterior and apical compartments, regardless of stage
* Patient with preoperative dyspareunia (patients with mild sexual discomfort related to prolapse may be included
* Patient presents with preoperative stress urinary incontinence responsible of significant functional incapacity (response ≥2 to question 17 of PFDI-20 questionnaire).
* Indication for concomitant suburethral sling
* Patient with previous history of surgery for stress urinary incontinence
* Indication of concomitant perineorrhaphy surgery with or without myorrhaphy (in both groups).
* Contra-indication for general anesthetic
* Current urinary infection
* Current vaginal infection

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No